Pre–exposure prophylaxis of HIV: British HIV Association 2018 Guidelines

British HIV Association and the British Association of Sexual Health and HIV have released 2018 Guidelines on pre-exposure prophylaxis (PrEP)of HIV. The guidelines include a series of recommendations of PrEP including recommendations for gay men and men who have sex with men, heterosexual men and women, people who inject drugs, trans people and young people.

Following are the major recommendations.

1. Evidence for safety and efficacy in men who have sex with men (MSM): recommendations

• We recommend that pre-exposure prophylaxis,PrEP with on‐demand or daily oral TD‐FTC should be offered to HIV‐negative MSM who are identified as being at elevated risk of HIV acquisition through condomless anal sex in the previous 6 months and ongoing condomless anal sex.


• We recommend that PrEP with on‐demand or daily oral TD‐FTC should be offered to HIV‐negative MSM having condomless anal sex with partners who are HIV positive, unless the partner has been on ART for at least 6 months and their plasma viral load is <200 copies/mL.


• We suggest that tenofovir alone should not currently be offered as PrEP to MSM. This recommendation is based on lack of evidence, rather than evidence of lack of effect.

2. Evidence for safety and efficacy in heterosexual populations: recommendations

• We recommend that daily oral TD‐FTC should be offered to HIV‐negative heterosexual men and women having condomless sex with partners who are HIV positive, unless the partner has been on ART for at least 6 months and their plasma viral load is <200 copies/mL.


• We suggest that PrEP with daily oral TD‐FTC should be offered on a case‐by‐case basis to heterosexual men and women with current factors that may put them at increased risk of HIV acquisition. See Section 5.1.


• We recommend that TDF alone can be offered to heterosexual men and women where FTC is contraindicated.

3. Evidence for safety and efficacy in people who inject drugs (PWID): recommendations

• We suggest that PrEP is not recommended for people who inject drugs where needle exchange and opiate substitution programmes are available and accessed by the individual.


• We recommend that existing harm‐reduction strategies such as needle exchange and opiate substitution programmes should be encouraged for people who inject drugs.

4. Evidence for safety and efficacy in trans people: recommendations

• We recommend that PrEP with daily oral TD‐FTC should be offered to HIV‐negative trans women who are identified as being at elevated risk of HIV acquisition through condomless anal sex in the previous 6 months and ongoing condomless sex.


• We recommend that daily oral TD‐FTC should be offered to HIV‐negative trans women and trans men having condomless sex with partners who are HIV positive, unless the partner has been on ART for at least 6 months and their plasma viral load is <200 copies/mL.

5. Evidence for safety and efficacy in young people (15–25 years): recommendations

• We recommend that PrEP with daily or on‐demand oral TD‐FTC should be offered to young MSM (15–25 years) who are identified as being at elevated risk of HIV acquisition through condomless anal sex in the previous 6 months and ongoing condomless anal sex.


• We recommend that PrEP with TD‐FTC should be offered to young people having condomless anal sex with partners who are HIV positive, unless the partner has been on ART for at least 6 months and their plasma viral load is <200 copies/mL.


• We recommend that PrEP with daily oral TD‐FTC should be offered to young HIV‐negative trans women who are identified as being at elevated risk of HIV acquisition through condomless anal sex in the previous 6 months and ongoing condomless sex.


• Routine BMD scanning in young people initiating PrEP is not recommended.

6. Evidence for the timelines for starting and stopping PrEP: recommendations

• We recommend that, if the risk of HIV acquisition is through anal sex, PrEP can be started with a double dose of TD‐FTC taken 2–24 h before sex and continued daily until 48 h after the last sexual risk.


• We recommend that if PrEP for anal sex has been interrupted and it is <7 days since the last TD‐FTC dose then PrEP can be re‐started with a single dose of TD‐FTC.


• We recommend that if the risk of HIV acquisition is through vaginal sex, PrEP should be started as a daily regimen 7 days ahead of the likely risk and continued daily for 7 days after the last sexual risk.

7. How to identify those at risk of HIV infection: recommendations

• We recommend that PrEP with daily or on‐demand oral TD‐FTC is offered to MSM and trans women at elevated risk of HIV acquisition through recent (6 months) and ongoing condomless anal sex.


• We recommend that PrEP with daily oral TD‐FTC is offered to HIV‐negative people having condomless sex with partners who are HIV positive, unless the partner has been on ART for at least 6 months and their plasma viral load is <200 copies/mL.

8. Baseline assessment and testing: recommendations

• We recommend that baseline HIV testing with a combined antigen/antibody serology test is undertaken prior to commencing PrEP.


• We recommend that same‐day initiation of PrEP may occur where an individual has a negative third‐generation or higher blood‐based POCT on the day, or a negative combined HIV antigen/antibody test within the past 4 weeks.


• We recommend that an HIV viral load should be considered where a high‐risk exposure has occurred within 4 weeks.


• We recommend that initiation of PrEP is deferred in people reporting condomless anal sex in the previous 4 weeks who have symptoms suggestive of HIV seroconversion until an HIV RNA result is available.


• We recommend that baseline screening for hepatitis B should be undertaken in those of unknown hepatitis B status to exclude active hepatitis B infection with vaccination initiated in those who are non‐immune.


• We recommend assessment by a specialist in viral hepatitis/co‐infection for those with evidence of chronic HBV with regard to continuing therapy or safety of stopping therapy.


• We recommend that on‐demand PrEP dosing should not be considered in people with chronic HBV infection.


• We recommend that baseline screening for hepatitis C should be undertaken in MSM and other groups at risk of HCV.


• We recommend a full STI screen at baseline including syphilis serology and NAAT testing for gonococcal and chlamydial infection at sites of exposure (genital, rectal, pharyngeal).


• We recommend that baseline renal function is assessed with a serum creatinine, eGFR and urinalysis but PrEP can be commenced while waiting for the results.


• We suggest that the eGFR for individuals starting TDF is >60 mL/min/1.73 m².


• We suggest that individuals with eGFR <60 mL/min/1.73 m² should be started on PrEP only on a case‐by‐case basis and after a full assessment and discussion with the patient of the risk and benefits and obtaining specialist renal advice.

9. Other considerations: recommendations

• We suggest that if an individual is pregnant when starting PrEP or becomes pregnant while on PrEP, that they continue PrEP during pregnancy or breastfeeding if there is an ongoing risk of HIV acquisition, after discussing the potential risks of TD‐FTC.

10. Prescribing PrEP: recommendations

• We recommend that tenofovir/emtricitabine (TD‐FTC) fixed‐dose combination, dosed appropriately, is used for HIV pre‐exposure prophylaxis for men who have sex with men (MSM), trans women and heterosexual men and women who are at high risk of HIV acquisition.


• We recommend that for heterosexual men and women only, tenofovir alone may be considered.


• We recommend the following lead in periods:

• For on‐demand or daily dosing in anal sex, the time to clinical protection in rectal tissues is estimated as 2–24 h following a double dose of TD‐FTC.


• For daily dosing (with single dose TD‐FTC), the time to protection for vaginal sex is estimated as 7 days.

• Frequency of dosing:

• We recommend daily PrEP can be offered to MSM, trans men, trans women and heterosexual men and women at high risk of HIV.


• We recommend that MSM and trans women should be advised that daily PrEP is likely to be ineffective if fewer than four doses are taken per week. There is no evidence in other populations that four doses instead of seven per week is adequate .


• On‐demand PrEP can be discussed and offered to MSM. A loading dose of two tablets of TD‐FTC taken 2–24 h before sex, followed by a third (single) tablet 24 h and a fourth (single) tablet 48 h later is advised. Where potential exposure is sustained over more than a 24‐h period, one pill per day should be taken until the last sexual intercourse followed by the two postexposure pills.


• In the absence of data, we do not recommend on‐demand dosing in heterosexual men and women.

11. Monitoring on PrEP: recommendations

• We recommend HIV testing should be undertaken every 3 months with a laboratory combined HIV antigen/antibody test (1A) or a blood‐based POCT.


• We recommend that patients with symptoms suggestive of seroconversion should be investigated with a combined HIV antigen/antibody test and HIV viral load. Atypical testing results should be discussed with a regional expert.


• We recommend that in confirmed primary HIV infection, baseline resistance testing should be undertaken. This is to look for evidence of resistance‐associated mutations to tenofovir or emtricitabine along with other transmitted mutations.


• We recommend 3‐monthly screening for bacterial STIs (chlamydia, gonorrhoea and syphilis) in all taking PrEP and 3‐monthly HCV testing in MSM, trans women and others at on‐going risk of HCV.


• Renal recommendations:

• If eGFR >90 mL/min/1.73 m² at baseline (and follow‐up) and the person is aged <40 years then annual eGFR should be conducted.


• If eGFR 60–90 mL/min/1.73 m², aged >40 years or concomitant risk factors for renal impairment, more frequent monitoring of renal function at physician discretion is recommended but should be at least 6 monthly.


• If eGFR <60 mL/min/1.73 m², the risks and benefits of continuing PrEP should be assessed on a case‐by‐case basis. Specialist renal input should be obtained to determine further investigations and frequency of monitoring.

12. Indications for stopping PrEP: recommendations

• We recommend that a positive HIV test is an absolute contraindication to continued PrEP. Referral to specialist HIV services should be undertaken immediately for investigation and management including intensification of ART regimen.


• We recommend assessment by a specialist in viral hepatitis/co‐infection for those with chronic HBV with regard to the safety of stopping TD‐FTC prior to discontinuing therapy.


• We recommend that for those at high risk of HIV acquisition, suboptimal adherence is a relative contraindication to continued use.


• We recommend that, in those without vaccine‐induced immunity, HBV infection should be excluded prior to stopping TD‐FTC.